The application of statistical methods is specified all through 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries for these activities:
o Setting validation criteria and specifications
o Performing Measurement Systems Analysis (MSA)
o Conducting stability analysis
o Using Design of Experiment (DOE) for process development and validation
o Developing process control charts
o Determining process capability indices.
The Quality System Regulation (QSR) for medical devices states that manufacturers should take steps, where appropriate, for establishing and maintaining procedures with which to identify valid statistical techniques needed to establish, control, and verify that the process capability and product characteristics are acceptable.
Methods are specified in 21 CFR and guidance documents
Both 21 CFR and guidance documents emphasize the need for statistical methods from discovery through product discontinuation. While 21 CFR specifies the suitable statistical procedures needed to establish both in-process and final specifications; the guidance documents require applying statistical methods for development and validation of measurement systems, process understanding using Quality by Design (QbD) principles, process validation, as well as ensuring that the manufacturing process is in a state of control and is capable.
Even though many statistical methods may be applied to fulfil this part of the QSR; there exist a few commonly accepted methods that all companies can and preferably should use for:
o Developing acceptance criteria
o Ensuring accurate and precise measurement systems
o Fully characterizing manufacturing processes
o Monitoring and controlling process results, and
o Selecting an appropriate number of samples.
Learn the dynamics of statistical methods
The nitty gritty of application of statistical methods will be the teaching a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will be offering. At this seminar, Heath Rushing, who is the cofounder of Adsurgo and author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP; will be the Director.
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. To understand the areas of implementation of statistical methods that comply with the requirements set out in CFR 21 and guidance documents, please enroll for this session by visiting “Understanding the practical application of statistics”
A full description of statistical processes
This course provides instruction on the statistical methods for data analysis of applications related to the pharmaceutical, biopharmaceutical, and medical device industries. The Director will explain the appropriate statistical approaches: descriptive statistics, data intervals, hypothesis testing, ANOVA, regression, ANCOVA, and model building need to be applied. Upon establishment of competence in each of these areas; he will present the way these need to be applied in an industry-specific manner.
During the course of these two days, Heath will cover the following areas:
· Describe and analyze the distribution of data
· Develop summary statistics
· Generate and analyze statistical intervals and hypothesis tests to make data-driven decisions
· Describe the relationship between and among two or more factors or responses
· Understand issues related to sampling and calculate appropriate sample sizes
· Use statistical intervals to setting specifications/develop acceptance criteria
· Use Measurement Systems Analysis (MSA) to estimate variance associated with: repeatability, intermediate precision, and reproducibility
· Ensure your process is in (statistical) control and capable.